MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 302

Model Number 302-20

Device Problems Corroded (1131); Fracture (1260); Device Contamination with Body Fluid (2317)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/13/2019

Event Type  malfunction  

Event Description

It was reported that during the generator replacement for the patient, high impedance was seen when the leads were attached to the new generator.The previous generator could not be interrogated due to battery depletion prior to surgery and therefore high impedance was not seen on the patient's previously implanted generator.The surgeon elected to explant and replace the lead noting a fracture was visible in the lead.The patient's leads have been received into product analysis however analysis as not been completed to date.No additional relevant information has been received to date.

Event Description

Lead analysis completed.The lead was explanted and returned due to fracture of leads and high impedance and these allegations were confirmed in product analysis (pa) lab.Note that a portion of the lead assembly (body) including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead.During the visual analysis the connector ring quadfilar coil appeared to be broken approximately 175mm from the end of the connector boot.The coils strands were mechanically damaged with pitting.The remaining broken coil strands were identified as having stress induced fractures and mechanical damage, no putting.It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting.The coil shows characteristics typical of lead discontinuity (material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution).The abraded openings found in the outer and connector ring inner silicone tubing and the cut ends that were made during the explant process most likely provided the leakage path for the dried remnants of what appeared to be body fluids.For the observed connector pin inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends.With the exception of the observed discontinuity the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure.No other obvious anomalies were noted.The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present.Continuity checks of the returned lead portion were performed during the visual analysis and no other discontinuities were identified.Based on the findings in the pa lab, there is evidence to suggest a discontinuity in the returned portion of the lead may have contributed to the fracture of leads and high impedance.Note that since a portion of the lead assembly (body) including the electrodes was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.Generator analysis was also completed on the generator that was opened but not used in the patient.The allegation of high impedance was not duplicated in the pa lab.Various electrical loads were attached to the generator and results of the diagnostic tests demonstrate accurate resistance measurements.The pulse generator diagnostics were as expected for the programmed parameters.A comprehensive automated electrical evaluation showed that the device performed according to functional specifications.

Event Description

Implant form was received from day of surgery reporting that high impedance was seen.No additional relevant information has been received to date.

Manufacturer Narrative

Section b6.Relevant tests/laboratory data, including dates; corrected data: impedance value known and inadvertently not reported in initial mdr.

• Brand Name: LEAD MODEL 302
• Type of Device: LEAD
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 9167693
• MDR Text Key: 161713803
• Report Number: 1644487-2019-01958
• Device Sequence Number: 1
• Product Code: MUZ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2008
• Device Model Number: 302-20
• Device Lot Number: 1547
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2019
• Event Location: Other
• Date Manufacturer Received: 11/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 41 YR